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Merck & Co. and Schering-Plough will pay $41.5 million to settle class-action lawsuits filed by patients taking their shared cholesterol drugs Vytorin and Zetia, the companies said Wednesday.

The joint venture, Merck/Schering-Plough Pharmaceuticals (MSP), recorded these charges in the second quarter 2009 to cover the settlement's cost, a spokesman for Merck said.

The lawsuits involved allegations stemming from the Enhance clinical trial, whose results in January 2008 cast doubt on the efficacy of Zetia (ezetimibe) and Vytorin (simvastatin).

Vytorin is a combination drug made up of Merck’s Zocor, a statin drug, and Schering-Plouugh’s Zetia, a newer cholesterol lowering drug.

The settlement resolves some 145 lawsuits pending in U.S. District Court for the District of New Jersey that were seeking class-action status to represent consumers and insurers who purchased, used or paid money toward the purchase of Vytorin or Zetia.

The settlement is not an admission of liability or misconduct in connection with the marketing or sale of Vytorin or Zetia or plaintiffs' allegations relating to the Enhance study.

The agreement involves two settlements - one with insurers and the other with consumers who purchased, used or paid money toward the purchase of Vytorin and Zetia. The consumer settlements require court approval.

The Enhance study found Vytorin was no better at reducing plaque buildup then generic brand Zocor which has been on the market for more than two years.

Zytorin was approved by the Food and Drug Administration in 2002, on the basis of drug trials involving 3,900 patients for 12 weeks, not long enough to determine if the drug reduced heart attacks or cardiovascular disease. #

2 Comments

Posted by JILL PAUL RNWednesday, August 05, 2009 8:30 PM EST

Chrissie, a settlement of 41.5 million for a drug that didn't reduce cholesterol! Cholesterol is something that can be monitored by lab work and if the drug is not working, can be changed very easily for another. What if you had a defective medical device implanted in you at great expense and it failed through no fault of your own? This is the reason why I am such a strong advocate of The Medical Device Safety Act. These injured people have no where to turn and the medical device manufacturers' will not accept reponsibility for their own products. The meeting in Washington yesterday on MDSA left me quite disgusted with those not in favor of the bill. All I can say is that they must be in someone's hip pocket and should be investigated by the Attorney's. I did see the video in its entirety.

Jill, I agree with you wholeheartedly. The more I read about MDSA, the more I just don't understand how people aren't *MORE* supportive.

I very much enjoy reading all of your helpful and informative comments! Thank you!

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